Regional Submission Planner

Pharma and Clinical Research

INTRODUCTION

Do you have pharma regulatory experience? Are you looking for full-time? If you are, read on, we have a great opportunity for you to support one of the world’s most prestigious pharma companies. You will be part of a multicultural team helping develop and apply strategies to ensure regulatory compliance. You will have the opportunity to be a link of communication with our stakeholders. We want to help you develop your career in a global environment while contributing to health safety.

In our Life Science Department, you will work within the Client organization, in the Regulatory Affairs Operations Regional department (EMEA Region).

FUNCTION

  • Support the regulatory submission creation and the registration tracking of the company, the regulatory submission targets from a regulatory operational perspective for the whole region.
  • Review and manage the complexity of planning, managing, tracking, assembling and delivering of regulatory content, to meet regulatory strategy, regulatory compliance and informational needs of regional regulatory authority.
  • Help with project management tasks, including managing dynamic timelines, interacting and negotiating and collaborating with global stakeholders

 

Your main functions would be:

  • Managing operational aspects of submission planning for assigned products.
  • submission planning
  • document retrieval
  • submission creation and delivery to Health Authorities

REQUIREMENTS

  • Bachelor’s degree in a Life Science related discipline.
  • High level expertise and knowledge of the regulatory landscape, its registration procedures and a thorough understanding of the technical requirements for dossiers (e.g. eCTD and other submission formats).
  • Affinity to work with complex IT systems
  • English language knowledge, intermediate or above
  • At least 2 years experience in the regulatory operations area, regulatory affairs will be an asset.

OFFER

  • Attractive salary & cafeteria benefits
  • Pleasant work atmosphere: open office environment, relax rooms, terraces
  • Workplace stability
  • Inhouse gym
  • Health Care Benefit
  • Hungarian language courses for non-Hungarian speakers
  • Self-development training
  • Global and diverse working environment
  • Company events
  • Team building activities

CONTACT INFO

Natacha Pinto
Email address: natacha.pinto@tcs.com

Would you like to work with TCS Hungary?
Send your CV to
natacha.pinto@tcs.com
and mention the name of the open
position in your email!